Cognitive and Fusion Prostatic Biopsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive-targeted prostate biopsy.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: No limits · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cognitive Versus Image Guided Fusion Transrectal Prostatic Biopsy for the Detection of Prostate Cancer
Overview
The goal of this study is to compare two different prostate biopsy techniques used to detect prostate cancer. These techniques are cognitive-targeted biopsy (CTB) and magnetic resonance imaging-ultrasound fusion-targeted transrectal biopsy (FTB). Both methods aim to improve the accuracy of prostate cancer detection by targeting suspicious areas identified on prostate imaging. This study will compare how accurately each technique detects prostate cancer, the pathological findings obtained from each biopsy method, and how operator performance may influence the procedure. The information gained from this study may help improve prostate cancer diagnosis and guide future biopsy practices.
Detailed description
This study will be conducted in the urology department, Menoufia University, and will include biopsy-naïve patients with clinical suspicion of prostate cancer. Suspicion will be based on abnormal digital rectal examination (DRE) findings and prostate-specific antigen (PSA) levels between 4 and 20 nanograms per milliliter (ng/mL).
All eligible patients will undergo multiparametric magnetic resonance imaging (mpMRI) of the prostate using a 1.5-Tesla scanner. Imaging will be interpreted by a single experienced radiologist. Only patients with lesions scored as Prostate Imaging-Reporting and Data System (PI-RADS) category 4 or 5 will be included in the study.
Participants who meet the inclusion criteria will undergo both cognitive-targeted biopsy (CTB) and magnetic resonance imaging-ultrasound fusion-targeted biopsy (FTB) during the same biopsy session. Biopsies will be performed under local or regional anesthesia using the BK3000 ultrasound system.
The study will assess predefined procedural and pathological parameters, including histopathological findings (presence or absence of malignancy and International Society of Urological Pathology \[ISUP\] grade group), lesion location by prostate zone and orientation, serum prostate-specific antigen and prostate-specific antigen density, lesion length, and procedure duration. Procedures will be performed by two operators (surgeon 1 and surgeon 2) according to the study protocol.
No results are reported in this section. Study outcomes will be entered in the results section after study completion.
Interventions
- Procedure Cognitive-targeted prostate biopsy
Participants will undergo a cognitive-targeted prostate biopsy followed immediately by a fusion-targeted prostate biopsy during the same session.
Primary outcome measures
- Prostate Cancer Detection Rate Assessed by Histopathological Examination [Time frame: During the biopsy session]
- Clinically Significant Prostate Cancer Detection Rate Defined by International Society of Urological Pathology Grade Group [Time frame: During the biopsy session]
Secondary outcome measures (3)
- Biopsy Procedure Time Measured in Minutes [Time frame: During the procedure]
- Target Lesion Length Measured on Multiparametric Magnetic Resonance Imaging [Time frame: Before the biopsy procedure]
- Procedural Metrics According to Surgeon Assignment [Time frame: During the biopsy procedure]
Eligibility criteria
Inclusion criteria
Biopsy-naïve patients
Prostate-specific antigen level between 4 and 20 ng/mL
Multiparametric Magnetic Resonance Imaging Prostate Imaging-Reporting and Data System score 4 or 5
Exclusion criteria
Prior prostate biopsy
Prostate-specific Antigen level outside the specified range
Contraindication to Magnetic Resonance Imaging
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Egypt · 2 centers
- Menoufia university hospital urology department — Shibīn al Kawm
- Menoufia university hospital urology department — Shibīn al Kawm
Identifiers
NCT: NCT07306741 · UROL 22